Study Evaluating the Impact of the 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Alaskan Native Children.

NCT00743652

Last updated date
Study Location
Pfizer Investigational Site
Akiak, Alaska, 99552, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Disease, 13-valent Pneumococcal Vaccine
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
42 + days
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male or female infants 6 weeks to < 5years of age in good health, available for the entire study period and reachable by phone, parents able to complete all relevant study procedures.

- Infants who have received Prevnar are eligible to participate, but this is not required.

- Infants participating in the blood draws must live in a specific identified area (Yukon Kuskokwim Delta region)

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Contraindication to vaccination with pneumococcal vaccine or allergic reaction to any
vaccines or vaccine related components, immune deficiency, bleeding disorder or major
known congenital malformation.

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Pneumococcal Disease, 13-valent Pneumococcal VaccineStudy Evaluating the Impact of the 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Alaskan Native Children.
NCT00743652
  1. Akiak, Alaska
  2. Bethel, Alaska
  3. Chefornak, Alaska
  4. Chevak, Alaska
  5. Eek, Alaska
  6. Emmonak, Alaska
  7. Hooper Bay, Alaska
  8. Kasigluk, Alaska
  9. Kongiganak, Alaska
  10. Kotlik, Alaska
  11. Kwethluk, Alaska
  12. Kwigillingok, Alaska
  13. Mtn. Village, Alaska
  14. Napaskiak, Alaska
  15. Newtok, Alaska
  16. Nunapitchuk, Alaska
  17. Russian Mission, Alaska
  18. Scammon Bay, Alaska
  19. Toksook Bay, Alaska
  20. Tuluksak, Alaska
  21. Upper Kalskag, Alaska
ALL GENDERS
42 Days+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating the Impact of the 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Alaskan Native Children.
Official Title  ICMJE A Phase 3, Open Label Trial Evaluating the Safety, Immunogenicity and Impact of 13-valent Pneumococcal Conjugate Vaccine in Alaskan Native Children.
Brief Summary This study is to evaluate the safety, immunogenicity and impact of 13-valent Pneumococcal conjugate vaccine in Alaskan Native Children.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Pneumococcal Disease
  • 13-valent Pneumococcal Vaccine
Intervention  ICMJE
  • Biological: 13-valent Pneumococcal Conjugate Vaccine
    4 doses of 13vPnC (0.5ml, IM) will be administered. (3 doses infant series, and 1 toddler dose)
  • Biological: 13-valent Pneumococcal Conjugate Vaccine
    3 doses of 13vPnC (0.5ml, IM) will be administered. (2 doses for infant series catch-up, and 1 toddler dose)
  • Biological: 13-valent Pneumococcal Conjugate Vaccine
    2 doses of 13vPnC (0.5ml, IM) will be administered. (1 dose infant series catch-up, and 1 toddler dose)
  • Biological: 13-valent Pneumococcal Conjugate Vaccine
    2 doses of 13vPnC (0.5ml, IM) will be administered. (2 catch-up dose(s) greater than 60 days apart )
  • Biological: 13-valent Pneumococcal Conjugate Vaccine
    1 dose of 13vPnC (0.5ml, IM) will be administered. (1 catch-up dose)
Study Arms  ICMJE
  • Experimental: Group1
    Subjects 6 weeks to <10 months of age with 0 prior dose of Prevnar.
    Intervention: Biological: 13-valent Pneumococcal Conjugate Vaccine
  • Experimental: Group 2
    Subjects <12 months of age with 1 prior dose of Prevnar.
    Intervention: Biological: 13-valent Pneumococcal Conjugate Vaccine
  • Experimental: Group 3
    Subjects <12 months of age with 2 prior doses of Prevnar.
    Intervention: Biological: 13-valent Pneumococcal Conjugate Vaccine
  • Experimental: Group 4
    Subjects ?12 months to <2 years of age.
    Intervention: Biological: 13-valent Pneumococcal Conjugate Vaccine
  • Experimental: Group 5
    Subjects ?2 years to <5 years of age
    Intervention: Biological: 13-valent Pneumococcal Conjugate Vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 18, 2011)
373
Original Estimated Enrollment  ICMJE
 (submitted: August 28, 2008)
2500
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female infants 6 weeks to < 5years of age in good health, available for the entire study period and reachable by phone, parents able to complete all relevant study procedures.
  • Infants who have received Prevnar are eligible to participate, but this is not required.
  • Infants participating in the blood draws must live in a specific identified area (Yukon Kuskokwim Delta region)

Exclusion Criteria:

  • Contraindication to vaccination with pneumococcal vaccine or allergic reaction to any vaccines or vaccine related components, immune deficiency, bleeding disorder or major known congenital malformation.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 42 Days to 5 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00743652
Other Study ID Numbers  ICMJE 6096A1-3010
B1851009
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP